MAUDE Adverse Event Report: SEASPINE INC. MARINER MIS PEDICLE SCREW SYSTEM; CORTICAL SHANK, CANNULATED

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

No implants were made available for review as the hardware remains in-situ.Additionally, the patient is reported to be fused and asymptomatic.The surgeon plans to monitor the patient for any indication prompting surgical intervention; however, it is not believed to be necessary at this time from a clinical standpoint.Review of the x-ray provided confirms the screw fracture reported.Review of labeling: possible adverse events.Bending, disassembly or fracture of implant and components.

Event Description

The patient underwent a 3-level spinal surgery consisting of seaspine's mariner pedicle screw system from level l3-s1.The index surgery date is unknown.Seaspine was made aware on (b)(6) 2020 of a post-operative left s1 screw fracture.

• Brand Name: MARINER MIS PEDICLE SCREW SYSTEM
• Type of Device: CORTICAL SHANK, CANNULATED
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: audrey mudderman ; 5770 armada drive; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 10908940
• MDR Text Key: 241399833
• Report Number: 3012120772-2020-00089
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1